Gcp Qa Auditor

2+ years

Not Disclosed

Columbus,

10 Oct. 23, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Summary
Due to our rapid growth, we are seeking experienced industry professionals to join our Quality Assurance (QA) team. This position will support and audit global trials across various therapeutic areas, ensuring compliance with organizational and regulatory standards. As a vital member of our Quality Assurance department, your expertise will contribute significantly to our success.

Responsibilities

Serve as a Quality Program Lead on clinical trials, ensuring adherence to national and international regulatory standards for pharmaceuticals, biologics, and medical devices.
Develop audit management plans and strategies in collaboration with clients for ongoing clinical trials.
Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines.
Assist in creating departmental standard operating procedures, work instructions, forms, and templates.
Assess the validated state and security of proprietary and cloud-based software.
Develop training materials and interactive tests, including company-wide regulatory training (ICH/GCP).

Qualifications

Bachelor’s degree in life sciences or a related field.
2-5 years of experience in a QA department within a related industry.
Experience conducting audits of vendors and investigative sites.
Experience hosting regulatory authorities and interacting with sponsor/client representatives.
Independent thinking and strong planning abilities.
Comprehensive knowledge and application of Good Clinical Practice (GCP).
Experience with medical devices and/or Phase 1 trials is a plus.
Ability to travel up to 30%-40% of the time.
Excellent written and verbal communication skills.
Strong teamwork skills and the ability to work independently.

Medpace Overview
Medpace is a full-service clinical contract research organization (CRO) that provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ over 5,000 people across 40+ countries.

Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted countless patients and families facing various diseases across key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Cincinnati Perks

Hybrid work-from-home options (dependent upon position and level)
Competitive PTO packages, starting at 20+ days
Competitive compensation and benefits package
Flexible work schedule
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Community involvement with local nonprofit organizations
Discounts on local sports games, fitness gyms, and attractions
Modern, eco-friendly campus with an on-site fitness center
Structured career paths with opportunities for professional growth
Discounted tuition for UC online programs

Awards

Named a Top Workplace in 2024 by The Cincinnati Enquirer
Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024
Continually honored with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.

Join Medpace and make a difference!

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Gcp Qa Auditor

Job Description

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